Kornimate/medical-research-clean huggingface dataset:
cohabitation patterns and incidence of known and suspected sexually transmitted diseases

Conditions: Cohabitation Patterns; Sexually Transmitted Diseases

Summary: the number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria. the various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other ways conducive of cancer development. suspicion of an infectious cancer origin may arise because of clustering with other conditions (e.g. immune deficiency), specific environments or settings (e.g. geographic locales) or with exposures (e.g. blood transfusions). in this context, relatively few studies have addressed clustering of diseases among spouses to generate hypotheses about the relative contributions of environmental and genetic factors to the risk of individual cancer types. as a prelude to such an exercise aiming specifically at malignant hematologic diseases, we will test an algorithm characterising cohabitation patterns in the danish population to assess the risk of sexually transmitted diseases in analyses of register data. such information will also be relevant to current guidelines for blood donor deferral policies. specifically, because of the so-called precautionary principle all blood donations are extensively tested for infectious agents and transfusion of blood now carries an extremely low risk of transmission of hiv, hepatitis b and c. the residual risk of hiv transmission in denmark is estimated to 1:10,000,000 transfusions. however, several deferral criteria have existed for years without studies to prove their relevance. aim: to compare the incidence of both known and suspected sexually transmitted diseases between different cohabitation patterns in the danish population. perspectives: the study results can be used to leverage changes in deferral rules in the danish blood banks to accommodate strong wishes from stakeholders to avoid the perceived discrimination of various minorities. the study can thus have important ethical and political consequences.


Eligibility criteria:
inclusion criteria: * all citizens in denmark exclusion criteria: * institutionalized individuals
a long-term safety and efficacy study agn-19920 in patients with persistent erythema associated with rosacea

Conditions: Erythema; Rosacea

Summary: this study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (hcl) cream 1.0% (agn-199201) in patients with persistent erythema associated with rosacea.


Eligibility criteria:
inclusion criteria: -moderate to severe persistent facial erythema associated with rosacea. exclusion criteria: * current treatment with monoamine oxidase (mao) inhibitors * raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or sjogren's syndrome.
a study to assess the effects of mk0822 in reducing the risk of bone metastasis in women with breast cancer (0822-029)

Conditions: Breast Cancer

Summary: the purpose of this study is to test mk0822 on reducing the risk of bone metastasis in women with breast cancer.


Eligibility criteria:
inclusion criteria: * confirmed primary state ii or stage iii breast cancer * patient is not receiving adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) at the time of randomization and has not received adjuvant chemotherapy for at least 6 weeks prior to the randomization visit (visit 2). this inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7) * patient is not receiving hormonal therapy or if patient is receiving hormonal therapy (e.g., leuprolide, tamoxifen, anastrozole) she is on a stable regimen for at least 3 months at the time of screening (visit 1). if patient is her2-positive and is receiving trastuzumab treatment, she must be on a stable regimen for at least 1 month at the time of visit 1 * patient is not pregnant or breast-feeding. all women of childbearing potential must have a negative urine pregnancy test at screening (visit 1) exclusion criteria: * bone metastases or history of bone metastases * patient has evidence of other distant metastases (e.g., visceral, soft-tissue, or brain) * patient has had a prior local or regional recurrence of her breast cancer, or a contralateral tumor. dcis (ductal carcinoma in-situ), and lcis (local carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted * patient has any of the following: 1. is currently receiving a bisphosphonate or other drug therapy for osteoporosis 2. has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to visit 1, or for a total of more than 6 months at any time prior to visit 1 3. has been treated with an intravenous bisphosphonate within the 12 months prior to visit 1 * patient has a history of malignancy other than breast cancer \<5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. patients with melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are exclusionary * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent * patient is currently participating in or has at any time in the past participated in a breast cancer study with a registered medication (i.e., approved by the regulatory agency in which she resides) being tested for the treatment of breast cancer (an unapproved indication)
ketamine interleaved with electroconvulsive therapy for depression

Conditions: Depression

Summary: pragmatic, randomised, controlled, parallel group, pilot clinical trial of ketamine vs. midazolam interleaved with electroconvulsive therapy (ect) as an adjunctive treatment for a major depressive episode. the main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

patients referred for treatment with ect at st patrick's mental health services for treatment of a depressive episode will be eligible for recruitment to the clinical trial. participants will be invited to be randomised to a course of twice-weekly ketamine or midazolam infusions for the duration of ect. participants will receive the first allocated infusion following the first or second treatment with ect. block randomisation will be independently performed. infusions will be delivered on separate days to ect. physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions.treatment-as-usual will continue throughout the entire trial. trial interventions: participants will receive twice-weekly infusions of either ketamine at 0.5mg/kg or midazolam at 0.045mg/kg. all infusions will be administered by a consultant anaesthetist. repeated infusions of allocated drug have been shown to be safe and well tolerated by patients with mental illness. minor haemodynamic changes and psychotomimetic side effects can occur and will be assessed regularly during infusions and for 120 minutes afterwards. participants will be followed-up at six weeks and three months after the final infusion to assess for relapse according to standardised criteria.

Eligibility criteria:
inclusion criteria: * ≥18 years old * able to provide informed consent * voluntary admission for treatment of an acute depressive episode * meet dsm-v criteria for a major depressive disorder (mdd) and bipolar affective disorder (current episode depression) * montgomery asberg depression rating scale 10 item version (madrs) score of ≥20 * referred for treatment with ect * sufficiently physically healthy to receive ketamine/midazolam and ect exclusion criteria: * inability to provide informed consent * current involuntary admission * history of axis 1 diagnosis other than major depression * medical condition rendering unfit for ect * active suicidal intention * presence of major neurological or organic brain disorder * alcohol/substance dependence in previous six-months * pregnancy or inability to confirm use of adequate contraception during the trial * breastfeeding women * contraindications to ketamine * contraindications to midazolam

Keywords: ketamine electroconvulsive therapy depression ect
compliance to eras after gastric surgery

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (eras) program in patients undergoing gastric cancer surgery.

the feasibility and effectiveness of eras program for various major surgical procedures have been well studies in the literature. however, eras program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. in this study, we developed eras program for gastric cancer surgery, based on the systemic review about perioperative cares. the main elements of eras program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria. the aim of study is to evaluate the compliance to these main elements of eras program in patients undergoing gastric cancer surgery. previously reported data about eras program for colon surgery reported overall compliance as about 65%. considering that this is a single center study, we expected overall compliance rate of 70%. therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.

Eligibility criteria:
inclusion criteria: * patients who are to undergo gastric cancer surgery * asa score \< 3 * ecog performance status 0-1 * adequate hepatic, renal, and hematologic function * written informed consent exclusion criteria: * previous abdominal operation history * concommitant other organ malignant disease * preoperative chemotherapy or radiation therapy * concommitant other organ resection during surgery * emergency operation due to bleeding or perforation * active underlying medical illness * pregnancy

Keywords: gastric cancer perioperative care enhanced recovery after surgery multimodal rehabilitation fast track surgery gastrectomy
a study of a hypertensive population under treatment with micardis® and micardis plus® to control the early morning bp rise (surge ii)

Conditions: Hypertension

Summary: the primary objective was to evaluate, through the use of home blood pressure monitoring (hbpm), the degree of bp control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with micardis®, telmisartan or micardis plus®, telmisartan hydrochlorothiazide. the co-primary endpoints were the degree of bp control, and change from baseline until study end in mean systolic blood pressure (msbp) and mean diastolic blood pressure (mdbp) hbpm in the early morning hours after 8 weeks of treatment with micardis®, telmisartan or micardis plus®, telmisartan hydrochlorothiazide. secondary endpoints were office bp control rates, office bp response rates, and reduction in msbp and mdbp office blood pressure measurement (obpm) from baseline to final visit, discontinuations and tolerability


Eligibility criteria:
inclusion criteria: * patients male or female between 18 and 80 years of age * patients with mild to moderate essential hypertension * patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment exclusion criteria: * pre-menopausal women who have no birth control, who are pregnant or nursing * patients with advanced hepatic impairment or advanced renal impairment * patients with new york heart association (nyha) functional class iii or iv congestive heart failure (chf), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months * patients with any type of relevant arrhythmia according to the assessment of the investigator * patients with any valvular disease with hemodynamic repercussion * patients receiving chronic administration of oral anticoagulants or digoxin * patients with known hypersensitivity to any component in the formulation of micardis®, telmisartan or micardis plus®, telmisartan hydrochlorothiazide * patients with previous history of angioedema associated with angiotensin converting enzyme (ace) inhibitors * patients with severe, uncontrolled hypertension or any form of secondary hypertension * patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
a community trial to determine whether 'safe storage' reduces pesticide self-poisoning in rural asia

Conditions: Pesticide Poisoning

Summary: a major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. the aim of this work is to determine whether the provision of lockable storage containers to poor households in rural asia can reduce the incidence of intentional pesticide self-poisoning. secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.

we will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural sri lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning. the study will be based in anuradhapura district where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. randomisation will be clustered, with villages rather than households randomised. a census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed. the primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. we will use poisson regression models, taking account of clustering and stratification, for the analysis. the study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across asia.

Eligibility criteria:
inclusion criteria: * any village in the study area that gives consent to the study exclusion criteria: * none

Keywords: pesticide poisoning suicide unintentional poisoning prevention cluster randomised controlled trial
study of liver resection with versus without hepatic inflow occlusion for the hbv-related hcc

Conditions: Liver Cancer; Surgery

Summary: the study aims to compare the perioperative and long-term outcomes of liver resection for hbv-related hcc with versus without hepatic inflow occlusion.

high prevalence of hepatitis b virus (hbv) imposes a huge burden of hepatocellular carcinoma (hcc) in asia. liver resection remains the mainstay of treatment for hcc. hepatic inflow occlusion, known as the pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. a major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. and the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. this study aims to compare the perioperative and long-term outcomes of liver resection for hbv-related hcc without versus with hepatic inflow occlusion. this study will include eligible patients with hbv-related hcc elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). the secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. patients will be followed for up to five years. data will be statistically analyzed on an intention-to-treat basis. this prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for hbv-related hcc without vascular occlusion. clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.

Eligibility criteria:
inclusion criteria: 1. elective liver resection due to hbv-related hcc with barcelona-clinic liver cancer (bclc) staging 0 or a; 2. child-pugh classified a with or without cirrhosis, or reversed to a from b after conventional therapy; 3. tumors located either in the left or right hemiliver; 4. resection extent was a hemi-hepatectomy or less; 5. informed consent. exclusion criteria: 1. having comorbidity that contraindicates surgery; 2. participation in concurrent interventional trials with interference to this study; 3. eligible for laparoscopic hepatectomy; 4. requiring concomitant procedures, such as digestive, vascular or biliary reconstruction; 5. lack of compliance for treatment or future follow-up.

Keywords: liver resection blood inflow control ischemia-reperfusion injury inflammatory response randomized controlled trial
safety and immunogenicity of a four influenza vaccines in children ages 6 months old to less than 48 months old

Conditions: Influenza

Summary: to evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age


Eligibility criteria:
inclusion criteria: * healthy subject, male or female, 6 through \< 48 months of age at the time of enrollment, who has never previously received an influenza vaccine * individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up exclusion criteria: * individuals recently vaccinated against influenza * subjects with contraindications to receive influenza vaccine

Keywords: influenza children safety tolerability immunogenicity
ultra-low contrast angiography in aki

Conditions: Acute Kidney Injury

Summary: the aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

the study is a non-inferiority open-label randomized controlled trial. hospitalized patients who have aki at admission or who develop aki during admission and require invasive coronary angiography will be included in the trial. once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. immediate angiography will be performed within 24 of enrollment. serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. pre- and post-hydration administration will be at the discretion of the treating physician. in case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography. definitions: aki is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. cin is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.

Eligibility criteria:
inclusion criteria: * hospitalized patients who have aki at admission or who develop aki during admission and require invasive coronary angiography will be included in the trial. exclusion criteria: * stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment. * contraindication for invasive coronary angiography other than aki. * percutaneous coronary intervention is indicated and cannot be postponed by 7 days. * need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography). * administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography. * pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.

Keywords: coronary angiography ultra low contrast
hyper baric oxygen therapy (hbot) for spontaneous osteonecrosis of the knee

Conditions: Spontaneous Osteonecrosis of the Knee

Summary: safety and efficacy of hyper baric oxygen (hbo) in patients presenting with spontaneous osteonecrosis of the knee


Eligibility criteria:
inclusion criteria: * age40-85 years * diagnosis of spontaneous osteonecrosis of the knee (sonk)in last month, stage 1 or 2 by mri. exclusion criteria: * hyperbaric treatment (hbot) in the last 2 years. * any contraindication for hbot * pregnancy. * inability to sign inform consent * any contraindication for mri